An Evaluation of Prescription Drug Monitoring Programs

Transcription

1 An Evaluation of Prescription Drug Monitoring Programs Ronald Simeone and Lynn Holland Simeone Associates, Inc. September 1, 26 1 Abstract This research eamines the effects of Prescription Drug Monitoring Programs (PDMPs) on the supply and abuse of prescription drugs. Information from the Automation of Reports and Consolidated Orders System (ARCOS) is used to develop measures of supply, and information from the Treatment Episode Data Set (TEDS) is used to develop measures of abuse. Practical considerations lead us to focus on Schedule II pain relievers and stimulants, and composite measures for these two classes of drugs are developed. We estimate both aggregate and individual response models. The aggregate model suggests that PDMPs reduce the per capita supply of prescription pain relievers and stimulants and in so doing reduce the probability of abuse for these drugs. The evidence also suggests that states which are proactive in their approach to regulation are more effective in reducing the per capita supply of prescription pain relievers and stimulants than states which are reactive in their approach to regulation. The individual response model confirms these findings. It is important to note that the probability of pain reliever abuse is actually higher in states that have PDMPs than in states that do not. But our analysis demonstrates that in the absence of such programs the probability of abuse would be higher still. Key words: drug abuse, multilevel model, binary response model. 1 We would like to thank Dr. Roger Vaughan, Department of Biostatistics, Columbia University for his review and comments. Please direct all correspondence to Dr. Ronald Simeone, Simeone Associates Inc., 22 Lancaster Street, Albany, New York, 1221 ( This project was sponsored by the United States Department of Justice, Office of Justice Programs, Bureau of Justice Assistance (No. 25PMBXK189).

2 1 Introduction Twenty states have implemented systems to monitor the prescription and sale of drugs identified as controlled substances by the Drug Enforcement Administration (DEA). Another twenty-three states are in the process of designing or planning to design such systems. This growth is fueled in part by the Harold Rogers Prescription Drug Monitoring Program (PDMP). The competitive grant program, managed by the Bureau of Justice Assistance (BJA) in the Office of Justice Programs (OJP), is intended to support states wishing to enhance local capabilities to monitor the prescription and sale of controlled substances. States are eligible for these grants if they have in place, or have pending, an enabling statute or regulation requiring the submission of prescription data on controlled substances to a central database. States may also apply if they can introduce legislation or regulations for a prescription monitoring program before the annual OJP Hal Rogers Program grant cycle begins. Prescription Drug Monitoring Programs as they eist at the state level serve a variety of ends, but all are intended ultimately to reduce the abuse of controlled pharmaceutical substances. We focus on two possible channels by which a PDMP might affect the probability of prescription drug abuse. The first is indirect, operating through the supply of controlled substances. If a PDMP reduces the supply of prescription drugs, then this in turn may reduce the probability of abuse. The second is direct: when supply is held constant, a PDMP may itself reduce the probability of abuse. The former may be indicative principally of the effect that regulation has on prescribing behavior, whereas the latter may be indicative principally of the effect that regulation has on dispensing behavior. 1

3 The purpose of this research is to provide a statistical basis for assessing these effects. To this end, we propose a series of multilevel models for estimating the relationships among the presence of a PDMP, supply, and abuse. The specification of a two-equation multilevel model that makes use of repeated measurements of state characteristics provides a starting point for our analysis, and allows both the supply and abuse measures to be treated as endogenous to the PDMP measures. These relationships are eamined while controlling for other state-level characteristics that may be relevant to our task. But individuals, not states, choose to abuse drugs. Hence, results based on aggregate data can at best only suggest causality. At worst, they allow us to fall victim to the classic ecological fallacy (Robinson [1]; for discussion of circumstances under which generalization from aggregate to individual data is appropriate see Freedman et al. [2]; Greenland and Robins [3]; Freedman et al. [4]; Neeleman and Lewis [5]). To address this problem, we propose another multilevel model that makes use of repeated measurements made of individual characteristics that are likely to affect behavior. Both our aggregate and our individual response models will allow relationships to be eamined over time. Therefore, it is necessary that we select a common period during which data from all of our sources will be available for use in our analysis. This is the interval beginning January 1, 1997 and ending December 31, 23. We begin by discussing issues related to measurement in Section 2. An aggregate model involving equations for supply and abuse is presented and estimated in Section 3. An individual response model for abuse is presented and estimated in Section 4. Findings are discussed and directions for future research are suggested in Section 5. 2

4 2 Measurement The fundamental structure of our model, whether aggregate or individual response, involves three sets of measures: those related to the PDMP, those related to supply, and those related to abuse. Our ability to define these measures is constrained by data that are currently available for use in our analysis. The actual choices that we make are guided by our desire to develop a parsimonious model that avoids misspecification. PDMP data. In support of our research the National Alliance for Model State Drug Laws (NAMSDL) has assembled data that allow sources of variation in PDMP implementation to be eamined over time. and investigated. One of the most important of these is the manner in which cases are identified In some states the PDMP is "reactive" in nature, generating "solicited reports" only in response to a specific inquiry made by a prescriber, dispenser, or other party with appropriate authority. In other states the PDMP is "proactive" in nature, identifying and investigating cases, and generating "unsolicited reports" when it deems that this is warranted. It is important to maintain this distinction since program effects may vary by mode of implementation. Two measures of PDMP status are therefore constructed for each state, for each year. The first involves coding the presence or absence of any PDMP as 1 or (respectively). The second involves coding the presence or absence of a proactively monitoring PDMP in the same manner. Prescription Drug Monitoring Programs also differ in their scope of coverage, at one etreme including only Schedule II drugs, and at the other including Schedule II-V drugs. Coverage is cumulative; any state that regulates the prescription and sale of Schedule III drugs also regulates the prescription and sale of Schedule II drugs; any state that regulates the prescription and sale of Schedule IV drugs also regulates the prescription and sale of Schedule II and III drugs, and so on. 3

5 Because we seek to eamine whether the presence of a PDMP reduces supply it is reasonable to define supply in a manner consistent with the scope of its influence. The most straightforward way of accomplishing this is to limit elements of supply to Schedule II drugs. But the consequences associated with ecluding Schedule III-V drugs from our analysis warrants additional consideration. Supply data. Our source of data on supply is the Automation of Reports and Consolidated Orders System (ARCOS) maintained by the DEA Office of Diversion Control (ODC). ARCOS includes records on retail sales of twelve controlled substances (amphetamine, cocaine, codeine, fentanyl, hydrocodone, hydromorphone, methamphetamine, methylphenidate, meperidine, methadone, morphine, and oycodone). In support of our research the ODC has aggregated transactions for these drugs to the zip-code and state level and provided data on the number of grams sold for each year during our observation period. Tables I-IV provide information on the relationship between drug schedule and four types of drugs: "pain relievers", "tranquilizers", "stimulants" and "sedatives." This categorization scheme appears often in drug abuse research and has been adopted as a convention by the National Survey on Drug Use and Health (NSDUH) and other federal reporting systems. The tables were developed by Carnevale Associates, LLC (CALLC) using the Centers for Disease Control (CDC) National Drug Code (NDC) database. Generic drugs (shaded rows) and brand-name products are cross-classified by schedule for pain relievers, tranquilizers, stimulants and sedatives. Looking at the tables we see that the ARCOS drugs are principally Schedule II pain relievers (opioid agonists including codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, and oycodone) and Schedule II stimulants (dopamine agonists and reuptake inhibitors including amphetamine, cocaine, methamphetamine, and methylphenidate). 4

7 Table II: Tranquilizers Drug Schedule II Schedule III Schedule IV Schedule V alprazolam Xana chlordiazepoide Librium Limbitrol clonazepam Klonopin clorazepate Tranene diazepam Valium halazepam Paipam lorazepam Ativan oazepam Sera prazepam Centra quazepam Doral meprobamate Equanil Miltown Our research focuses on the indirect and direct effects of PDMPs on abuse. When assessing the indirect effects we estimate the relationship between the presence of a PDMP and supply, and the relationship between supply and abuse. It is therefore not unreasonable to limit our definition to include only drugs that are subject to PDMP control and which have significant abuse potential. Defining supply in terms of Schedule II drugs leads us to eclude codeine and hydrocodone since they are Schedule II drugs only in their generic forms. The most common brand name products for codeine (Tylenol with Codeine R ) and hydrocodone (Lortab R, Lorcet R and Vicodin R ) are regarded as having less potential for abuse, thus their status as Schedule III drugs. 6

8 amphetamine Adderall Biphetamine Deedrine Detrostat benzphetamine Didre diethylpropion Tenuate Tepanil mazindol Mazanor Sanore methamphetamine Desoyn methylphenidate Concerta Methylin Ritalin phendimetrazine Bontril Plegine Prelu-27 phentermine Adipe Fastin Ionamin Lonamin Table III: Stimulants Drug Schedule II Schedule III Schedule IV Schedule V There may be another argument for limiting our analysis to include Schedule II pain relievers and stimulants only. In eamining the impact of PDMPs on supply we would ideally make use of information on all sources of prescription drugs that might become candidates for abuse. Internet sales therefore become a concern because they constitute an unmeasured component of supply in each state. From a statistical perspective this problem would be less serious if the preponderance of internet sales involved Schedule III-V rather than Schedule II drugs. 7

9 There is some limited evidence to suggest that this may be the case. As the result of a massive investigation (Cyber Chase) conducted by the Organized Crime Drug Enforcement Task Force (OCDETF) a number of significant insights were gained into the operation of the Bansal organization, an India-based group that supplied controlled substances to rogue pharmacies operating Internet Facilitation Centers (IFCs) in the United States. The indictment (filed in the United States District Court for the Eastern District of Pennsylvania) indicates that during the period from "August 24...(to)...March 25 the defendants and others sold at least 4, dosage units of controlled substance pharmaceutical drugs in Schedule II, at least 2,7, dosage units of controlled substance pharmaceutical drugs in Schedule III, and at least 12,287, dosage units of controlled substance pharmaceutical drugs in Schedule IV..." to IFCs. In this case the preponderance of sales clearly involved Schedule III and IV drugs; and the majority of Schedule II sales involved codeine liquid. If this portfolio were representative of all internet-based trafficking activity, then our operational definition of supply would effectively eliminate at least one confounding factor. It is also important to differentiate drugs that are produced and distributed legally from drugs that are produced and distributed illegally. Prescription Drug Monitoring Programs do not regulate the production and distribution of illicit drugs. And this leads us to limit our definition of supply further, ecluding cocaine and methamphetamine from consideration. The elements of supply thus become fentanyl, hydromorphone, meperidine, methadone, morphine and oycodone (which we define collectively as pain relievers in subsequent sections) and amphetamine and methylphenidate (which we define collectively as stimulants in subsequent sections). 8

11 Because states differ in population size it is necessary to establish some appropriate basis for making comparisons among them. Thus, our measures of supply are defined as grams per capita for fentanyl, hydromorphone, meperidine, methadone, morphine and oycodone (pain relievers); and amphetamine and methylphenidate (stimulants). These are calculated for each state, for each year. The fact that there are a number of controlled substances under investigation and that each may be regarded as endogenous relative to the presence of a PDMP causes us to consider whether there are any methods that might be used to summarize our drug-specific per capita measures as one or more composite measures. Fentanyl, hydromorphone, meperidine, methadone, morphine and oycodone are all opioid agonists that have therapeutic utility because of their analgesic properties. The relative potency of these drugs has been eamined in some detail and therefore provides guidance to the construction of a general measure of supply for pain relievers. Findings from several surveys of studies that have attempted to establish equianalgesic dose ratios for opioid agonists are presented in Table V (Gordon et al. [6];Andersonet al. [7];Pereiraet al. [8]). Since research in this area often involves substitution of one drug for another, the order of rotation is regarded as important and therefore reported both in the literature and in our table. All ratios presented are epressed by route of administration (PO = oral, SC = subcutaneous, IV = intravenous) and relative to morphine. Therefore (reading across the first row entry in Table V) when rotating between morphine and fentanyl 1 mg. fentanyl administered subcutaneously is equivalent to 68 mg. morphine administered subcutaneously. 1

13 We use the information presented in Table V to develop a composite measure for pain relievers, weighting the number of grams for each drug (fentanyl, hydromorphone, meperidine, methadone, and oycodone) by the corresponding mean equianalgesic oral dose ratio presented there. Morphine serves as our calibration measure and receives a weight of 1. Summing over the weighted values and dividing by the corresponding population produces a composite per capita measure for pain relievers ("PR composite"). The composite measure is calculated for each state, for each year. 1 Fentanyl poses a problem because it is not ordinarily administered orally (although there is a lozenge available that is intended for sublingual use). We assume the relative potency of fentanyl administered orally to be equal to its relative potency when administered subcutaneously. While there is no direct evidence in support of this calculation, there is indirect evidence demonstrating similarity of equianalgesic dose ratios between hydromorphone administered orally and subcutaneously, and fentanyl and hydromorphone administered subcutaneously. By deduction, the assignment of this value seems reasonable. In any case, since our objective is simply to maintain some approimation to relative potency our assumption is not likely to introduce a significant source of measurement error. A measure comparable to PR composite is developed for stimulants ("ST composite") where, following convention established by standard dose-equivalence tables, the ratio of amphetamine to methylphenidate is assumed to be 2:1. As before, the composite measure is calculated for each state, for each year. 1 This approach is conceptually similar to various methods that have been used to estimate the availability of illicit drugs (heroin and cocaine). In such cases it is necessary to control for the presence of dilutants and adulterants. Standard measures of "grams pure" are therefore developed that can be eamined over time and relative to other factors such as price (see for eample Arkes et al. [21] who make use of a somewhat more refined model that incorporates informationonconsumerepectations). 12

14 The composites are intended to provide potency-adjusted measures of the total supply of pain relievers and stimulants in each state. Since the drugs in a particular group differ in potency and may not all move together in the same direction over time they may eert mutually offsetting effects on supply. The composites allow us to compensate for this. They also offer substantial consistency with the treatment admission-based measures of pain reliever and stimulant abuse that will be used in our analysis (we discuss this issue at length below). There are some general limitations associated with defining supply in terms of grams per capita. Anecdotal evidence suggests that drugs are not necessarily sold to patients in the same area in which they are purchased by dispensers. A large mail-order pharmaceutical house located in a particular state may thus distort estimates of supply that are based on purchases made by dispensers alone. At the same time, research on psychostimulants has produced empirical evidence demonstrating a strong relationship between per capita measures of grams ordered and the number of prescriptions filled at the zip code level (Bokhari et al. [22]). Abuse data. The Treatment Episode Data Set (TEDS) maintained by the Substance Abuse and Mental Health Services Administration (SAMHSA) constitutes our source of data on abuse. The system includes all individuals admitted to state-licensed drug treatment programs in the United States. Data are captured on state, Metropolitan Statistical Area (MSA), and Core-Based Statistical Area (CBSA); on demographics and prior treatment history; and perhaps most importantly for our purposes, on primary, secondary and tertiary substances of abuse. Since our measures of supply are limited to include Schedule II pain relievers and stimulants we constrain abuse accordingly. 13

15 Our measure for pain relievers is defined by TEDS codes for "non-prescription methadone" and "other opiates and synthetics" (which implicitly includes hydromorphone, meperidine, morphine and oycodone); and our measure for stimulants is defined by TEDS codes for "other amphetamines" (which eplicitly ecludes methamphetamine) and "other stimulants" (which is assumed to include methylphenidate). Any individual admitted to treatment with an indication that the primary, secondary or tertiary substance of abuse is a prescription pain reliever receives a value of 1 for the pain reliever measure ( otherwise); and any individual admitted to treatment with an indication that the primary, secondary or tertiary substance of abuse is a prescription stimulant receives a value of 1 for the stimulant measure( otherwise). Per capita measures of pain reliever and stimulant abuse are constructed by summing over these individual values and dividing by the corresponding population for each state, for each year. Defining abuse based upon treatment admissions carries with it some limitations as well. Although TEDS includes records on "first admissions" only (thereby ecluding all transfer activity) there is still some tendency for one individual to eperience multiple admissions during a calendar year. This is not common; nonetheless, the phenomenon does occur. Throughout the tet we refer to "individuals admitted to treatment" with this caveat in mind. It is also important to remember that admission to treatment represents the culmination of a pattern of behavior in which eperimentation leads to abuse and eventually to dependence. But many people who abuse drugs never seek treatment. And our own research shows that the probability of seeking treatment varies as a function of individual characteristics (Simeone et al. [23,24]). Thus, without modeling in some way the conditional probability of admission to treatment, we may be able to generalize only to those who actually seek treatment during a particular period of time. 14

16 3 A Multilevel Aggregate Model One factor that figures prominently in the decision to use a particular drug is the local availability of that drug. A relatively low supply may indicate a reduced probability of prescription for the drug; it may indicate a reduced probability that the drug will be diverted to the illicit market; and it may indicate a reduced level of convenience associated with obtaining the drug via illicit means. Figures 1-8 provide information on supply over time for each pain reliever and stimulant included in our analysis. Per capita measures are transformed to rates per 1, as an aid to the reader. We distinguish between states that do not have a PDMP program ("non-pdmp") and states that do ("PDMP"). There are upward secular trends for all pain relievers with the eception of meperidine; and rates for pain relievers are higher in non-pdmp states than in PDMP states for all pain relievers with the eception of hydromorphone. 2 The difference in rates between non-pdmp and PDMP states appears to be especially pronounced for oycodone (Figure 6). Findings are similar for stimulants. There are secular trends for amphetamine and methylphenidate; and in both cases the rates are higher for non-pdmp states than for PDMP states. Figures 9-16 provide the same information presented in Figures 1-8 with the eception being that here we distinguish between states that do not have a PDMP which monitors proactively ("non- XPDMP") and states that do ("XPDMP"). The findings are similar although the differences in rates that eist between non-xpdmp states and XPDMP states may be more pronounced than the differences in rates that eist between non-pdmp and PDMP states. 2 Methadone is something of a special case since it is prescribed both as a pain reliever and as a treatment for heroin addiction. Figure 4 depicts sales to pharmacies only. If we eamine sales to Narcotics Treatment Providers (NTPs) we see an upward secular trend in non-pdmp states; but a higher per capita rate generally in PDMP states. This likely reflects the relative sizes of heroin-using populations in non-pdmp and PDMP states. 15

20 Figures provide information on abuse involving pain relievers ("PR admissions") or stimulants ("ST admissions"). Per capita measures are again transformed to rates per 1, and we begin by distinguishing between non-pdmp states and PDMP states. There is a secular trend for pain relievers but not for stimulants. The rate of pain reliever admissions is lower in non-pdmp states than in PDMP states; and the rate of stimulant admissions is higher in non-pdmp states than in PDMP states. Figures provide the same information as that presented in Figures ecept that here we distinguish between non-xpdmp and XPDMP states. The findings essentially mirror those described above non-pdm P PDMP Figure 21. PR Admissions (Number per 1,) non-xpdmp XPDMP Figure 23. PR Admissions (Number per 1,) non-pdm P PDMP Figure 22. ST Admissions (Number per 1,) non-xpdm P XPDMP Figure 24. ST Admissions (Number per 1,) For completeness we provide numerical information in Table VI related to the trends that have been discussed in this section. Material is presented there on rates per 1, for the separate drugs that we have characterized as pain relievers and stimulants, for our composite measures of pain relievers and stimulants, and for treatment admissions that involve pain relievers and stimulants. 19

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